1. Field of Invention
This invention relates to clinical assays of biological fluids and, in particular, to a standardized method for such analysis.
2. Brief Statement of the Prior Art
The analysis of biological samples such as spinal fluid, blood serum, urine, saliva, etc. for components such as enzymes, hormones, and viruses is a highly complex procedure. Recent advancements have provided for the mass analysis of a sample of biological fluids for a host of unknown substances; however, this procedure requires individual treatment of samples for each of the unknown substances determined and utilizes relatively complex and costly instrumentation.
Several analytical procedures have been developed for the analysis of biological fluids including radioimmunoassay and enzyme-linked immunosorbent assay. These methods employ tracer-labelled substances in a direct or competitive assay. In the direct method, the unknown substance forms a reaction conjugate with the tracer-labelled reactant and then the subsequent assay will determine the concentration of the tracer bonded to the unknown substance. In the competitive procedure, the tracer-labelled substance competes with the unknown substance of the sample for conjugation with a known quantity of a reactive compound. The concentration of the tracer-labelled substance in the conjugated product reflects its concentration and the concentration of the unlabelled, unknown substance. In the enzymatic assay, the conjugated enzyme is analyzed, typically by exposing the material to a chromogenic substrate to yield a chromophore which is analyzed by fluoroscopic or colorimetric methods and in the radio-assay, a radioactive element labelled reactive compound is analyzed by radioactive counters.
While the aforementioned analytical procedures provide an elegant and precise analysis of biological fluids, vastly superior to previous bioassays, the procedures are quite complex and require costly instrumentation.